A Study of Avastin (Bevacizumab) in Patients With Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

NCT00806923 | Completed Phase 3

• 1 other identifier: BO17704
• Study Type: interventional
• Target: 1,044
• Locations: 20 countries
• Sites: 154

Brief Summary

This 3 arm study will evaluate the efficacy and safety of adding Avastin versus placebo to a standard chemotherapeutic regimen in patients with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) who have not received prior chemotherapy. The anticipated time of study treatment is until disease progression, and the target sample size is 500+ individuals.

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  Event driven

Secondary Outcomes (2)

• Efficacy: Duration of overall survival, time to treatment failure, response rate, and duration of response.

  Event driven

• Safety:AEs, laboratory tests, SAEs, coagulation parameters

  Throughout study

Study Arms (3)

1

EXPERIMENTAL

Drug: Cisplatin; Drug: Gemcitabine; Drug: bevacizumab [Avastin]

2

EXPERIMENTAL

Drug: Cisplatin; Drug: Gemcitabine; Drug: bevacizumab [Avastin]

3

PLACEBO COMPARATOR

Drug: Cisplatin; Drug: Gemcitabine; Drug: Placebo

Interventions

Cisplatin DRUG

80mg/m2 iv on day 1 of each 3 week cycle, for a maximum of 6 cycles

1; 2; 3

Gemcitabine DRUG

1250mg/m2 on days 1 and 8 of each 3 week cycle for a maximum of 6 cycles

1; 2; 3

Placebo DRUG

iv on day 1 of each 3 week cycle until disease progression

3

bevacizumab [Avastin] DRUG

15mg/kg 1v on day 1 of each 3 week cycle until disease progression

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients, \>=18 years of age;
• documented inoperable, locally advanced, metastatic or recurrent non-squamous NSCLC;
• adequate liver and kidney function;
• women of childbearing potential must have a negative serum pregnancy test within 7 days of starting study treatment.

You may not qualify if:

• prior chemotherapy or treatment with another systemic cancer therapy;
• surgery (including open biopsy), significant traumatic injury, or radiotherapy within the last 4 weeks prior to first dose of study treatment;
• brain metastasis or spinal cord compression;
• fertile men, and women of childbearing potential, not using adequate contraception;
• treatment with any other investigational agent, or participation in another clinical trial, within 30 days prior to entering the study.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (154)

Unknown Facility

Bahía Blanca, 8000, Argentina

Location

Unknown Facility

Buenos Aires, C1270AAE, Argentina

Location

Unknown Facility

Buenos Aires, C1426ANZ, Argentina

Location

Unknown Facility

Mendoza, 5500, Argentina

Location

Unknown Facility

San Miguel de Tucumán, 4000, Argentina

Location

Unknown Facility

Santa Fe, 03000, Argentina

Location

Unknown Facility

Santa Fe, 2000, Argentina

Location

Unknown Facility

Adelaide, 5011, Australia

Location

Unknown Facility

Adelaide, 5065, Australia

Location

Unknown Facility

Brisbane, 4029, Australia

Location

Unknown Facility

Canberra, 2606, Australia

Location

Unknown Facility

Kurralta Park, 5037, Australia

Location

Unknown Facility

Melbourne, 3128, Australia

Location

Unknown Facility

Parkville, 3052, Australia

Location

Unknown Facility

Perth, 6009, Australia

Location

Unknown Facility

Sydney, 2050, Australia

Location

Unknown Facility

Sydney, 2139, Australia

Location

Unknown Facility

Tugun, 4224, Australia

Location

Unknown Facility

Wollongong, 2500, Australia

Location

Unknown Facility

Brussels, 1200, Belgium

Location

Unknown Facility

Haine-Saint-Paul, 7100, Belgium

Location

Unknown Facility

Leuven, 3000, Belgium

Location

Unknown Facility

Liège, 4000, Belgium

Location

Unknown Facility

Belo Horizonte, 30150321, Brazil

Location

Unknown Facility

Porto Alegre, 90020-090, Brazil

Location

Unknown Facility

Rio de Janeiro, 20231-050, Brazil

Location

Unknown Facility

São Paulo, 01221-020, Brazil

Location

Unknown Facility

Plovdiv, 4004, Bulgaria

Location

Unknown Facility

Sofia, 1527, Bulgaria

Location

Unknown Facility

Sofia, 1756, Bulgaria

Location

Unknown Facility

Stara Zagora, 8000, Bulgaria

Location

Unknown Facility

Varna, 9002, Bulgaria

Location

Unknown Facility

Veliko Tarnovo, 5000, Bulgaria

Location

Unknown Facility

Calgary, Alberta, T2N 4N2, Canada

Location

Unknown Facility

Edmonton, Alberta, T6G 1Z2, Canada

Location

Unknown Facility

Victoria, British Columbia, V8R 6V5, Canada

Location

Unknown Facility

Moncton, New Brunswick, E1C 8X3, Canada

Location

Unknown Facility

London, Ontario, N6A 4L6, Canada

Location

Unknown Facility

Mississauga, Ontario, L5M 2N1, Canada

Location

Unknown Facility

Newmarket, Ontario, L3Y 2P9, Canada

Location

Unknown Facility

Toronto, Ontario, M5G 1X5, Canada

Location

Unknown Facility

Toronto, Ontario, M5G 2M9, Canada

Location

Unknown Facility

Toronto, Ontario, M9N 1N8, Canada

Location

Unknown Facility

Greenfield Park, Quebec, J4V 2H1, Canada

Location

Unknown Facility

Montreal, Quebec, H2L 4M1, Canada

Location

Unknown Facility

Montreal, Quebec, H2W 1S6, Canada

Location

Unknown Facility

Sainte-Foy, Quebec, G1V 4G2, Canada

Location

Unknown Facility

Ostrava, 703 84, Czechia

Location

Unknown Facility

Ostrava, 708 52, Czechia

Location

Unknown Facility

Prague, 180 01, Czechia

Location

Unknown Facility

Ústí nad Labem, 401 13, Czechia

Location

Unknown Facility

Belfort, 90016, France

Location

Unknown Facility

Bobigny, 93009, France

Location

Unknown Facility

Caen, 14076, France

Location

Unknown Facility

Lyon, 69004, France

Location

Unknown Facility

Marseille, 13273, France

Location

Unknown Facility

Montbéliard, 25209, France

Location

Unknown Facility

Montpellier, 34295, France

Location

Unknown Facility

Pierre-Bénite, 69495, France

Location

Unknown Facility

Rennes, 35033, France

Location

Unknown Facility

Rouen, 76000, France

Location

Unknown Facility

Saint-Herblain, 44805, France

Location

Unknown Facility

Strasbourg, 67091, France

Location

Unknown Facility

Vandœuvre-lès-Nancy, 54511, France

Location

Unknown Facility

Berlin, 14165, Germany

Location

Unknown Facility

Essen, 45122, Germany

Location

Unknown Facility

Gauting, 82131, Germany

Location

Unknown Facility

Göttingen, 37075, Germany

Location

Unknown Facility

Hamburg, 20246, Germany

Location

Unknown Facility

Hamburg, 21075, Germany

Location

Unknown Facility

Hamburg, 22045, Germany

Location

Unknown Facility

Heidelberg, 69126, Germany

Location

Unknown Facility

Hemer, 58675, Germany

Location

Unknown Facility

Karlsruhe, 76137, Germany

Location

Unknown Facility

Leverkusen, 51375, Germany

Location

Unknown Facility

Mainz, 55131, Germany

Location

Unknown Facility

Mannheim, 68167, Germany

Location

Unknown Facility

München, 80336, Germany

Location

Unknown Facility

Alexandroupoli, 68100, Greece

Location

Unknown Facility

Athens, 11522, Greece

Location

Unknown Facility

Athens, 11527, Greece

Location

Unknown Facility

Thessaloniki, 57010, Greece

Location

Unknown Facility

Hong Kong, 852, Hong Kong

Location

Unknown Facility

Hong Kong, Hong Kong

Location

Unknown Facility

Budapest, 1529, Hungary

Location

Unknown Facility

Mosdós, 7257, Hungary

Location

Unknown Facility

Nyíregyháza, 4400, Hungary

Location

Unknown Facility

Székesfehérvár, 8001, Hungary

Location

Unknown Facility

Szombathely, 9700, Hungary

Location

Unknown Facility

Zalaegerszeg, 8901, Hungary

Location

Unknown Facility

Jerusalem, 91120, Israel

Location

Unknown Facility

Kfar Saba, 44281, Israel

Location

Unknown Facility

Petah Tikva, 49100, Israel

Location

Unknown Facility

Ramat Gan, 52621, Israel

Location

Unknown Facility

Tel Aviv, 6423906, Israel

Location

Unknown Facility

Candiolo, 10060, Italy

Location

Unknown Facility

Catania, 95123, Italy

Location

Unknown Facility

Genova, 16132, Italy

Location

Unknown Facility

Milan, 20133, Italy

Location

Unknown Facility

Milan, 20162, Italy

Location

Unknown Facility

Napoli, 80131, Italy

Location

Unknown Facility

Parma, 43100, Italy

Location

Unknown Facility

Perugia, 06132, Italy

Location

Unknown Facility

Reggio Emilia, 42100, Italy

Location

Unknown Facility

Roma, 00152, Italy

Location

Unknown Facility

Roma, 00168, Italy

Location

Unknown Facility

Rozzano, 20089, Italy

Location

Unknown Facility

Gdansk, 80-214, Poland

Location

Unknown Facility

Gdynia, 81-519, Poland

Location

Unknown Facility

Lublin, 20-950, Poland

Location

Unknown Facility

Olsztyn, 10-228, Poland

Location

Unknown Facility

Poznan, 60-569, Poland

Location

Unknown Facility

Szczecin, 70-891, Poland

Location

Unknown Facility

Warsaw, 02-781, Poland

Location

Unknown Facility

Balashikha, 143900, Russia

Location

Unknown Facility

Moscow, 105229, Russia

Location

Unknown Facility

Moscow, 107005, Russia

Location

Unknown Facility

Moscow, 115478, Russia

Location

Unknown Facility

Moscow, 123098, Russia

Location

Unknown Facility

Moscow, 143423, Russia

Location

Unknown Facility

Saint Petersburg, 197089, Russia

Location

Unknown Facility

Saint Petersburg, 197758, Russia

Location

Unknown Facility

Saint Petersburg, 198255, Russia

Location

Unknown Facility

Alicante, 03010, Spain

Location

Unknown Facility

Barakaldo, 48903, Spain

Location

Unknown Facility

Barcelona, 08035, Spain

Location

Unknown Facility

Barcelona, 08036, Spain

Location

Unknown Facility

Barcelona, 08907, Spain

Location

Unknown Facility

Girona, 17007, Spain

Location

Unknown Facility

Madrid, 28040, Spain

Location

Unknown Facility

Madrid, 28041, Spain

Location

Unknown Facility

Madrid, 28046, Spain

Location

Unknown Facility

Madrid, 28222, Spain

Location

Unknown Facility

Málaga, 29010, Spain

Location

Unknown Facility

San Cristóbal de La Laguna, 38320, Spain

Location

Unknown Facility

Seville, 41013, Spain

Location

Unknown Facility

Seville, 41014, Spain

Location

Unknown Facility

Valencia, 41014, Spain

Location

Unknown Facility

Valencia, 46009, Spain

Location

Unknown Facility

Valencia, 46010, Spain

Location

Unknown Facility

Valencia, 46015, Spain

Location

Unknown Facility

Kueishan, 333, Taiwan

Location

Unknown Facility

Taichung, 404, Taiwan

Location

Unknown Facility

Taichung, 407, Taiwan

Location

Unknown Facility

Taipei, 105, Taiwan

Location

Unknown Facility

Taipei, Taiwan

Location

Unknown Facility

Bangkok, 10400, Thailand

Location

Unknown Facility

Chiang Mai, 50200, Thailand

Location

Unknown Facility

Guildford, GU2 7XX, United Kingdom

Location

Unknown Facility

London, N18 1QX, United Kingdom

Location

Unknown Facility

Manchester, M2O 4BX, United Kingdom

Location

Unknown Facility

Sheffield, S10 2SJ, United Kingdom

Location

Unknown Facility

Sutton, SM2 5PT, United Kingdom

Location

Unknown Facility

Yeovil, BA21 4AT, United Kingdom

Location

Related Publications (3)

• Leighl NB, Bennouna J, Yi J, Moore N, Hambleton J, Hurwitz H. Bleeding events in bevacizumab-treated cancer patients who received full-dose anticoagulation and remained on study. Br J Cancer. 2011 Feb 1;104(3):413-8. doi: 10.1038/sj.bjc.6606074. Epub 2011 Jan 18.

  PMID: 21245868 DERIVED

• Leighl NB, Zatloukal P, Mezger J, Ramlau R, Moore N, Reck M, Manegold C. Efficacy and safety of bevacizumab-based therapy in elderly patients with advanced or recurrent nonsquamous non-small cell lung cancer in the phase III BO17704 study (AVAiL). J Thorac Oncol. 2010 Dec;5(12):1970-6. doi: 10.1097/JTO.0b013e3181f49c22.

  PMID: 20978447 DERIVED

• Reck M, von Pawel J, Zatloukal P, Ramlau R, Gorbounova V, Hirsh V, Leighl N, Mezger J, Archer V, Moore N, Manegold C; BO17704 Study Group. Overall survival with cisplatin-gemcitabine and bevacizumab or placebo as first-line therapy for nonsquamous non-small-cell lung cancer: results from a randomised phase III trial (AVAiL). Ann Oncol. 2010 Sep;21(9):1804-1809. doi: 10.1093/annonc/mdq020. Epub 2010 Feb 11.

  PMID: 20150572 DERIVED

MeSH Terms

Interventions

Cisplatin; Gemcitabine; Bevacizumab

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2008
• First Posted: December 11, 2008
• Study Start: February 1, 2005
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

CZ (4); GR (4); IL (5); AR (7); AU (12); GB (6); TW (5); TH (2); CA (14); HU (6); PL (7); BR (4); FR (13); ES (18); BE (4); DE (14); HK (2); IT (12); BU (6); RU (9)